Roche begins probe into Avastin use for eye ailments

Roche has initiated an internal investigation following reports in India that Avastin, its drug approved to treat several types of advanced cancers, had been used in certain eye ailments and damaged the vision of 15 patients in Gujarat.Vikas Dandekar&DIVYA RAJAGOPAL | ET Bureau | January 23, 2016, 03:27 IST

MUMBAI: Swiss biotech giant Roche has initiated an internal investigation following reports in India that Avastin, its drug approved to treat several types of advanced cancers, had been used in certain eye ailments and damaged the vision of 15 patients in Gujarat.

Avastin is widely prescribed "off label" for AMD or wet age-related macular degeneration, a debilitating eye ailment. However, Roche has highlighted that the product is not developed or manufactured to meet intraocular standards. Lucentis, another drug sold in India by Novartis, is specifically approved to treat the condition.

India’s market for AMD treatment is growing and could be in the range of Rs 90-100 crore, according to experts. Lucentis has a dominant share in value terms but the use of Avastin may be significantly higher in terms of volume due to a lower price tag, experts suggested. However, the data is not audited as the products are mostly used in hospital settings.

Following the incident reported earlier this week, the Drug Controller General of India (DCGI) issued a public health alert on January 21 to the effect that state-level authorities monitor movement of the drug and its use in ophthalmology. The DCGI categorically noted that the drug is not approved for intra-vitreal use for ophthalmological purposes. The Gujarat drug regulator has asked distributors to recall one batch of Avastin, while another state Telangana has blocked the sale of all Avastin batches as a safety measure, news reports indicate. Some reports suggested that investigators will check whether the product used in Gujarat was counterfeit Avastin.

A Roche India spokesperson told ET the company welcomed the DCGI notice."We would like to reiterate that Avastin (bevacizumab) has not been approved for intraocular use by the US FDA, European Medicines Agency or the government of India," the company said.

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